What is the role of an IRB?

---

Key Points

• Institutional Review Boards/Committees are multidisciplinary teams established to review research proposals that involve human subjects, in order to protect human rights and promote ethical research conduct.
• IRBs/IRCs may approve, disapprove, or recommend modifications to research proposals to ensure that appropriate steps are taken to protect the research participants’ health, safety, and welfare.

---

Helpful Links, Videos and Online Courses

Overview

• Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials
  • An overview of the IRB from the U.S. Food and Drug Administration with links to other resources related to ethical research.
• Institutional Review Committee
  • List of IRCs around Nepal, published by the Nepal Health Research Council.
• Guidelines for Writing Thesis/Research Proposal
  • A guide to formatting and writing a research proposal/IRB from the National Academy of Medical Sciences in Nepal.

Videos

• Guiding Principles of Institutional Review Boards
  • A 4-minute video describing the purpose of the IRB and how to put together a team.
• Institutional Review Board Webinar
  • A longer and comprehensive webinar from the University of Texas Dallas that details the purpose of the IRB, aspects of ethical research, and how to get approval for a research study.
• How IRBs Protect Human Research Subjects
  • 7-minute video from the U.S. Department of Health and Human Services that explains how IRBs protect the rights and health of human subjects in medical research.

---

Relevant Publications

• Nepal Health Research Council (NHRC). (2011). National Ethical Guidelines for Health Research in Nepal and Standard Operating Procedures. Kathmandu, Nepal.

---

What is the Nepal Health Research Council (NHRC) and what is their mission?

---

More Information

• To find out more about the NHRC and the various resources they offer, please visit their website.

What are important principles to conduct ethical research?

---

Key Points

• Ethical considerations in clinical research describe the types of ethical rules that should be followed when conducting experiments or studies. These ethical guidelines are often shaped by historical events and are put in place to prevent future unethical research practices.
• These ethical considerations are abided by according to guidelines provided by certain international documents, such as The Belmont Report (provided below).

---

Helpful Links, Videos and Online Courses

Overview

• The Belmont Report
  • Ethical Principles and Guidelines for the Protection of Human Subjects of Research from The Belmont Report, a prototype of ethical guidance.
• Ethical Considerations in Human Subjects Research
  • Short Appendix that explains the topics of Institutional Review Boards (IRB) and the process of getting approved for your own study.
• Human Subjects in Research
  • Dives into the rules, regulations, principles, and guidelines of having human subjects within a study. Also has great Works Cited list with further resources.
• The Helsinki Declaration
  • This document was created by the World Health Organization (WHO) in 1964 as a statement for ethical research practices on human individuals including human material and data that may be part of said research.

Videos

• Ethics of Research with Human Subjects
  • This 4-minute video from the University of Pennsylvania (Penn) Medical Ethics and Health Policy gives clear and concise outlines for the ethical guidelines that need to be followed while conducting a study.

---